On October 3, 2018, at a hearing before the U.S. Senate Subcommittee on Antitrust, Competition Policy, and Consumer Rights (“Hearing”), Makan Delrahim, the Assistant Attorney General for the Antitrust Division of the Department of Justice (“DOJ”), announced efforts by DOJ to “modernize and speed up the process of merger review.” Among other things, DOJ stated that it would endeavor to resolve most merger investigations within six months of filings. Relatedly, DOJ plans to make modifications to its second request process, including reforms to its timing agreements with merging parties.
On October 10, 2018, President Donald Trump signed into law the “Know the Lowest Price Act” and the “Patients’ Right to Know Drug Prices Act,” which aim to improve consumer access to drug price information by banning gag clauses. The Trump administration previously announced its intention to enact this legislation in its May 2018 Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and will likely point to these new federal laws as affirmation of its commitment to drug pricing reform that favors patients and consumers.
FDA Addresses Allegations of “Gaming” The Generic Drug Approval Process Through The Use of Citizen Petitions
On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions. Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), published on the same day. The stated goal of this revision was to create a more efficient approach to 505(q) petitions and to allow the Agency to focus reviewer resources on scientific reviews.
On October 16, 2018 the Department of Health and Human Services Office for Civil Rights (“OCR”) and the Office of the National Coordinator for Health Information Technology (“ONC”) announced an update to their previously provided Security Risk Assessment Tool. According to ONC and OCR, the “tool is designed to help healthcare providers conduct a security risk assessment” as required under the HIPAA Security Rule. ONC states that the updated tool includes additional features such as:
Davis Malm is pleased to announce that 20 of its attorneys were named to the list of 2018 Massachusetts Super Lawyers and Rising Stars. The results will be published in Boston magazine and in New England Super Lawyers, which is published by Thomson Reuters.
The FDA issued a new Draft Guidance today to ensure medical devices – an increasing potential target for hackers – are better protected from unauthorized digital access.
On September 28, 2018, the U.S. Food and Drug Administration (FDA) released two draft guidances for industry. The purpose, according to FDA Commissioner Scott Gottlieb, M.D., is to modernize the approach to clinical trial design in efforts to (1) make clinical trials more efficient while maintaining patient safety and (2) increase the amount of information concerning product safety and benefits. The two draft guidances are entitled: “Master Protocols – Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics” and “Adaptive Designs for Clinical Trials of Drug and Biologics.” This is the second of the two-part blog series describing the updates to the agency’s recommended approach to incorporating master protocols in clinical trials of new drugs and biological products for the treatment of cancer. The first of the two-part blog series described FDA’s recommended considerations to “adaptive designs” used in clinical trials.
Two draft guidances issued together late last month seek to increase both clinical trial efficiency and the amount of information that is available about a drug’s safety and benefits. The two draft guidances address, respectively, adaptive designs and master protocols. This blog post discusses FDA’s recommendations for adaptive designs; master protocols will be addressed in a subsequent blog post.
Davis Malm Attorneys Serve As Contributing Authors for ILN’s 2018 Edition of “Establishing a Business Entity: An International Guide”
Davis Malm is pleased to announce the release of the International Lawyers Network’s (ILN) fifth edition of their corporate guide, “Establishing a Business Entity: An International Guide.” This collaborative electronic guide offers a summary of key corporate law principles in 40 countries across the globe, serving as a quick, practical reference for those establishing an entity in these jurisdictions. The firm’s attorneys served as co-authors for the chapter on “Establishing a Business Entity in the United States.”
On August 8, 2018, the Internal Revenue Service (IRS) released proposed regulations (REG-107892-18) that address the operation and calculation of the 20% deduction for qualified business income (QBI) under newly enacted Section 199A of the Internal Revenue Code (the “Code”). These proposed regulations would apply to a domestic business operated as a sole proprietorship, partnership (including a limited liability company taxed as a partnership), S corporation, trust, or estate.